Ignite Creation Date:
2024-05-05 @ 11:45 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00128947
Status:
COMPLETED
Last Update Posted:
2008-03-04
First Post:
2005-08-09
Brief Title:
Pharmacokinetics of Mycophenolate Mofetil in Healthy Volunteers
Sponsor:
National Institutes of Health Clinical Center CC
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Pharmacokinetics of Mycophenolic Acid and Mycophenolate 7-O-Phenolic Glucuronide in Healthy Subjects With or Without Two Common Genetic Polymorphisms in the Promoter Region of Uridine Diphosphate Glucuronosyltransferase 1A9
Status:
COMPLETED
Status Verified Date:
2006-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study will examine how people differ in the way their bodies process and eliminate mycophenolate mofetil MMF a drug that is used to treat problems affecting the eye and immune system and to prevent organ rejection in transplant patients MMF is metabolized by a group of enzymes called UGTs each of which is made by a different gene This study will investigate whether people with different UGT genes differ in how well their bodies use and remove MMF The results may help scientists learn the best way to give MMF to patients
Normal healthy volunteers between 18 and 55 years of age may be eligible for this study Candidates are screened with a medical history physical examination and blood and urine tests including a blood test for analysis of genes that control and regulate UGTs Pregnant women and nursing mothers are excluded from the study Women who are able to have a child and men who can father a child must either abstain from sex or use two reliable forms of birth control during the study and for 3 months after its completion
Participants come to the NIH Clinical Center at 630 am on the first day of the study and stay in the outpatient clinic for 12 hours The next 4 mornings they return to the Clinical Center for a single blood collection The procedures for the 5 days are as follows
Day 1
Upon arrival at the Clinical Center a catheter is inserted into the subjects arm vein At 700 AM the subject takes one dose of MMF by mouth with a glass of water Small blood samples are collected through the catheter before the MMF dose and again at 05 1 15 2 3 4 6 8 10 and 12 hours after taking the drug Heart rate and blood pressure are measured before the blood collection and then every 4 hours After the last blood sample is collected the volunteer can return home
Days 2-5
Volunteers come to the Clinical Center at 700 AM on study days 2 3 4 and 5 for a single blood draw collected using a needle
Volunteers are contacted by telephone 1 2 and 3 months after completing the study to see how they are doing and to check on their pregnancy status and use of appropriate birth control
Normal healthy volunteers between 18 and 55 years of age may be eligible for this study Candidates are screened with a medical history physical examination and blood and urine tests including a blood test for analysis of genes that control and regulate UGTs Pregnant women and nursing mothers are excluded from the study Women who are able to have a child and men who can father a child must either abstain from sex or use two reliable forms of birth control during the study and for 3 months after its completion
Participants come to the NIH Clinical Center at 630 am on the first day of the study and stay in the outpatient clinic for 12 hours The next 4 mornings they return to the Clinical Center for a single blood collection The procedures for the 5 days are as follows
Day 1
Upon arrival at the Clinical Center a catheter is inserted into the subjects arm vein At 700 AM the subject takes one dose of MMF by mouth with a glass of water Small blood samples are collected through the catheter before the MMF dose and again at 05 1 15 2 3 4 6 8 10 and 12 hours after taking the drug Heart rate and blood pressure are measured before the blood collection and then every 4 hours After the last blood sample is collected the volunteer can return home
Days 2-5
Volunteers come to the Clinical Center at 700 AM on study days 2 3 4 and 5 for a single blood draw collected using a needle
Volunteers are contacted by telephone 1 2 and 3 months after completing the study to see how they are doing and to check on their pregnancy status and use of appropriate birth control
Detailed Description:
The immunosuppressant mycophenolate mofetil MMF is metabolized by several uridine diphosphate glucuronosyltransferases UGTs among which UGT1A9 is the most important enzyme Two commonly occurring single nucleotide polymorphisms SNPs in the promoter region of the UGT1A9 gene have been shown to enhance UGT1A9 protein level and activity in vitro This study is to investigate the potential in vivo effects of these two SNPs on the metabolism and hence the pharmacokinetics of MMF metabolites One hundred and thirty healthy volunteers will be screened for the presence of UGT1A9 C-2152T and T-275A polymorphisms Seventeen subjects who carry the variant alleles along with 17 others who do not have the polymorphisms will be selected to participate in the pharmacokinetic study Pharmacokinetics of the metabolites mycophenolic acid active and mycophenolate 7-O-phenolic glucuronide inactive will be determined and parameter values will be compared between the two groups It is hypothesized that the metabolism of MMF is enhanced in subjects with the two SNPs resulting in an increase in clearance and a decrease in the exposure of mycophenolic acid
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 05-CC-0209 | None | None | None |